The Union government on Tuesday said it has approved Gilead Sciences Inc’s antiviral drug remdesivir for emergency use in treating COVID-19 patients.
Remdesivir is the first drug to show improvement in COVID-19 patients in formal clinical trials. It was granted emergency use authorisation by the US Food and Drug Administration last month and has received approval by Japanese health regulators.
“(Remdesivir) approved on June 1 under emergency use with condition for five dose administration,” the Drugs Controller General of India said in an email statement to a news agency. Ministry of Health’s joint secretary Lav Agarwal also confirmed the same during a press briefing.
Remdesivir has been approved for emergency use for #COVID19
— PIB India #StayHome #StaySafe (@PIB_India) June 2, 2020
The drugmaker did not immediately respond to an email seeking further details.
As of Tuesday, India has 198,706 cases of coronavirus and has recorded 5,598 deaths, the Ministry of Health and Family Welfare data suggests.
Gilead Sciences had on Monday reported that remdesivir showed modest benefit in patients with moderate COVID-19 given a five-day course, while those who received it for 10 days in the study did not fare as well.
European and South Korean authorities are also looking at remdesivir, with South Korean health authorities last Friday saying they would request imports of the drug. Gilead is yet to gain regulatory approval in either market.